Recall archive / FDA device enforcement
CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators — FDA record Z-1754-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
- Reason
- There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- Classification
- Class I
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 12291 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1754-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN 00643169720657, Lot Serial Numbers: RPC203306H, RPC205335H, RPC207546H, RPC210227H, RPC205865H, RPC205916H, RPC205937H, RPC206296H, RPC206416H, RPC206665H, RPC207309H, RPC207864H, RPC208393H, RPC209253H, RPC209691H, RPC209707H, RPC209745H, RPC209762H, RPC209847H, RPC209918H, RPC209843H, RPC203399H, RPC204295H, RPC202725H, RPC207338H, RPC204122H, RPC210083H, RPC207179H, RPC207493H, RPC207715H, RPC208839H, RPC210208H, RPC210209H, RPC210279H, RPC202502H, RPC206685H, RPC207835H, RPC202337H, RPC203913H, RPC206604H, RPC206605H, RPC206608H, RPC206609H, RPC207319H, RPC207608H, RPC209946H, RPC207476H, RPC208004H, RPC205236H, RPC207257H, RPC202491H, RPC202610H, RPC203628H, RPC203989H, RPC204238H, RPC204412H, RPC204523H, RPC205585H, RPC210162H, RPC202353H, RPC202434H, RPC202549H, RPC202947H, RPC203116H, RPC207575H, RPC202513H, RPC205862H, RPC207849H, RPC209388H, RPC210124H, RPC203780H, RPC204065H, RPC204066H, RPC210111H, RPC204504H, RPC203114H, RPC205516H, RPC205847H, RPC207025H, RPC207175H, RPC204556H, RPC207683H, RPC208161H, RPC208598H, RPC208896H, RPC209484H, RPC203280H, RPC203999H, RPC204866H, RPC204869H, RPC204871H, RPC204874H, RPC205657H, RPC205859H, RPC205860H, RPC206559H, RPC206713H, RPC207077H, RPC207577H, RPC208079H, RPC208366H, RPC209001H, RPC209018H, RPC209067H, RPC209386H, RPC202652H, RPC203629H, RPC203149H, RPC204932H, RPC206900H, RPC208153H, RPC203547H, RPC203646H, RPC203649H, RPC203650H, RPC203657H, RPC204651H, RPC204964H, RPC205201H, RPC205208H, RPC205243H, RPC205257H, RPC205324H, RPC205418H, RPC205450H, RPC205886H, RPC206253H, RPC206303H, RPC206363H, RPC206405H, RPC206570H, RPC207011H, RPC207013H, RPC207164H, RPC207189H, RPC207223H, RPC207299H, RPC207317H, RPC207734H, RPC207944H, RPC208173H, RPC208687H, RPC208727H, RPC209119H, RPC209560H, RPC209751H, RPC210185H, RPC203519H, RPC204384H, RPC204719H, RPC208146H, RPC205717H, RPC206158H, RPC207008H, RPC207445H, RPC207612H, RPC207680H, RPC207685H, RPC209617H, RPC209618H, RPC204693H, RPC205822H, RPC205823H, RPC210256H, RPC207238H, RPC202405H, RPC205892H, RPC204308H, RPC206420H, RPC206768H, RPC209390H, RPC210007H, RPC202487H, RPC202490H, RPC202768H, RPC203159H, RPC203590H, RPC203876H, RPC204890H, RPC204891H, RPC206020H, RPC206954H, RPC207621H, RPC207623H, RPC207663H, RPC208020H, RPC208030H, RPC208081H, RPC208089H, RPC208132H, RPC208690H, RPC208692H, RPC209610H, RPC209914H, RPC209986H, RPC202800H, RPC209058H, RPC205273H, RPC202436H, RPC203284H, RPC203422H, RPC204104H, RPC206143H, RPC208006H, RPC210219H, RPC208606H, RPC209145H, RPC203499H, RPC203578H, RPC207574H, RPC202903H, RPC203763H, RPC204545H, RPC204971H, RPC205198H, RPC206098H, RPC207921H, RPC203330H, RPC205224H, RPC206462H, RPC207857H, RPC208082H, RPC208210H, RPC208256H, RPC202424H, RPC202650H, RPC202779H, RPC204250H, RPC204713H, RPC209333H, RPC203501H, RPC205234H, RPC203051H, RPC207629H, RPC208340H, RPC208652H, RPC209003H, RPC203480H, RPC205968H, RPC208556H, RPC208730H, RPC208793H, RPC208804H, RPC209252H, RPC203474H, RPC205364H, RPC206256H, RPC203908H, RPC204751H, RPC208722H, RPC201367H, RPC202661H, RPC203001H, RPC203014H, RPC203095H, RPC203419H, RPC203706H, RPC203727H, RPC203960H, RPC204006H, RPC204149H, RPC204439H, RPC204476H, RPC204709H, RPC205138H, RPC205353H, RPC205445H, RPC205448H, RPC205498H, RPC205535H, RPC205620H, RPC206028H, RPC206063H, RPC206071H, RPC206216H, RPC206218H, RPC206283H, RPC206318H, RPC206334H, RPC206367H, RPC206394H, RPC206422H, RPC207301H, RPC207388H, RPC207566H, RPC207820H, RPC208497H, RPC209361H, RPC209380H, RPC209902H, RPC210112H, RPC203745H, RPC206526H, RPC209877H, RPC203122H, RPC203277H, RPC205025H, RPC205910H, RPC206478H, RPC206893H, RPC206898H, RPC206903H, RPC208272H, RPC209424H, RPC206558H, RPC209332H, RPC202705H, RPC203112H, RPC203840H, RPC203842H, RPC204000H, RPC204321H, RPC206194H, RPC207505H, RPC209195H, RPC209215H, RPC203030H, RPC202546H, RPC203652H, RPC202680H, RPC203569H, RPC204416H, RPC204435H, RPC205287H, RPC205292H, RPC205529H, RPC205727H, RPC206550H, RPC207564H, RPC207866H, RPC207928H, RPC208277H, RPC209343H, RPC210122H, RPC203291H, RPC203568H, RPC202715H, RPC202395H, RPC203401H, RPC203540H, RPC205466H, RPC207199H, RPC204151H, RPC206221H, RPC209578H, RPC209607H, RPC202469H, RPC202753H, RPC203327H, RPC203625H, RPC203857H, RPC203916H, RPC203922H, RPC203924H, RPC204831H, RPC204833H, RPC204834H, RPC206439H, RPC206947H, RPC206964H, RPC207779H, RPC207780H, RPC207781H, RPC207782H, RPC203598H, RPC205099H, RPC204551H, RPC205084H, RPC205165H, RPC203529H, RPC203693H, RPC203934H, RPC203936H, RPC206633H, RPC207022H, RPC207023H, RPC207084H, RPC209062H, RPC202607H, RPC202691H, RPC203028H, RPC203263H, RPC204605H, RPC205621H, RPC206436H, RPC208191H, RPC209431H, RPC210156H, RPC206668H, RPC207602H, RPC202386H, RPC202917H, RPC203125H, RPC203156H, RPC203321H, RPC203322H, RPC204146H, RPC204147H, RPC204975H, RPC204978H, RPC204979H, RPC204982H, RPC204989H, RPC204990H, RPC204991H, RPC204992H, RPC204995H, RPC206356H, RPC207688H, RPC207692H, RPC207693H, RPC207966H, RPC209976H, RPC204061H, RPC204064H, RPC204079H, RPC204904H, RPC205019H, RPC205039H, RPC205220H, RPC205223H, RPC205403H, RPC205474H, RPC205475H, RPC205979H, RPC205981H, RPC205984H, RPC205986H, RPC205990H, RPC208700H, RPC208782H, RPC208786H, RPC208788H, RPC208791H, RPC208794H, RPC208795H, RPC208801H, RPC210082H, RPC205454H, RPC205455H, RPC205457H, RPC208869H, RPC203226H, RPC204264H, RPC205347H, RPC206417H, RPC207828H, RPC202411H, RPC204327H, RPC205094H, RPC208155H, RPC209198H, RPC209490H, RPC205349H, RPC203101H, RPC203825H, RPC205333H, RPC205472H, RPC206628H, RPC207290H, RPC207560H, RPC207627H, RPC208179H, RPC208220H, RPC208536H, RPC210102H, RPC203182H, RPC208717H, RPC203970H, RPC206281H, RPC206909H, RPC208119H, RPC209703H, RPC210266H, RPC209977H, RPC202670H, RPC205076H, RPC207410H, RPC209611H, RPC202566H, RPC203047H, RPC203308H, RPC203539H, RPC203948H, RPC203951H, RPC204071H, RPC205090H, RPC205998H, RPC205999H, RPC206512H, RPC206520H, RPC206897H, RPC207712H, RPC207957H, RPC208409H, RPC209183H, RPC209347H, RPC209723H, RPC202964H, RPC202965H, RPC203883H, RPC203885H, RPC204926H, RPC205412H, RPC206039H, RPC206049H, RPC206058H, RPC206059H, RPC206061H, RPC206065H, RPC206066H, RPC208419H, RPC209434H, RPC204036H, RPC204592H, RPC209148H, RPC202333H, RPC202378H, RPC202527H, RPC202831H, RPC204117H, RPC204275H, RPC204813H, RPC205006H, RPC205299H, RPC206304H, RPC206335H, RPC206830H, RPC207870H, RPC208029H, RPC209039H, RPC209581H, RPC210221H, RPC210239H, RPC204738H, RPC204746H, RPC206217H, RPC203006H, RPC205599H, RPC206031H, RPC206284H, RPC206368H, RPC207125H, RPC207976H, RPC209054H, RPC209487H, RPC209997H, RPC207846H, RPC210166H, RPC210168H, RPC203588H, RPC203896H, RPC204814H, RPC204816H, RPC205254H, RPC207522H, RPC203462H, RPC208240H, RPC208826H, RPC209954H, RPC206916H, RPC203485H, RPC209444H, RPC207314H, RPC210206H, RPC203836H, RPC204382H, RPC204684H, RPC206459H, RPC206749H, RPC207241H, RPC207495H, RPC208806H, RPC209020H, RPC210282H, RPC202505H, RPC202510H, RPC202853H, RPC203354H, RPC204717H, RPC206142H, RPC207217H, RPC209008H, RPC202441H, RPC206393H, RPC208547H, RPC203341H, RPC203654H, RPC207153H, RPC207557H, RPC207894H, RPC208515H, RPC205228H, RPC203461H, RPC203944H, RPC204302H, RPC209072H, RPC204129H, RPC205438H, RPC206571H, RPC206575H, RPC207303H, RPC207595H, RPC208832H, RPC208549H, RPC206931H, RPC207161H, RPC208346H, RPC208141H, RPC202440H, RPC203215H, RPC203538H, RPC207063H, RPC209676H, RPC209783H, RPC203528H, RPC205514H, RPC206339H, RPC208203H, RPC208281H, RPC209339H, RPC209582H, RPC202366H, RPC202664H, RPC205205H, RPC205277H, RPC207880H, RPC209376H, RPC207720H, RPC203100H, RPC206556H, RPC204585H, RPC209015H, RPC207590H, RPC207965H, RPC203506H, RPC204136H, RPC204607H, RPC204634H, RPC205017H, RPC205699H, RPC207016H, RPC207837H, RPC208937H, RPC209170H, RPC209246H, RPC209508H, RPC209878H, RPC203516H, RPC207284H, RPC208397H, RPC202567H, RPC208045H, RPC205741H, RPC209412H, RPC207923H, RPC207992H, RPC204613H, RPC205963H, RPC208835H, RPC209614H, RPC209139H, RPC202474H, RPC202757H, RPC202927H, RPC203000H, RPC203076H, RPC203345H, RPC203370H, RPC203653H, RPC204428H, RPC205042H, RPC205375H, RPC205588H, RPC206269H, RPC206396H, RPC206573H, RPC206630H, RPC206758H, RPC206939H, RPC206990H, RPC206993H, RPC207035H, RPC207163H, RPC207230H, RPC207271H, RPC207384H, RPC207475H, RPC207484H, RPC207551H, RPC208037H, RPC208147H, RPC208217H, RPC208247H, RPC208609H, RPC208661H, RPC208921H, RPC209134H, RPC209451H, RPC209608H, RPC210049H, RPC210214H, RPC202354H, RPC202412H, RPC202508H, RPC202816H, RPC202834H, RPC202879H, RPC202958H, RPC202971H, RPC203208H, RPC203217H, RPC203475H, RPC203509H, RPC203644H, RPC203759H, RPC203892H, RPC203938H, RPC204067H, RPC204157H, RPC204297H, RPC204356H, RPC204586H, RPC205168H, RPC205400H, RPC205401H, RPC205492H, RPC205586H, RPC205658H, RPC205750H, RPC206344H, RPC206686H, RPC207449H, RPC207841H, RPC207893H, RPC207972H, RPC208080H, RPC208098H, RPC208314H, RPC208564H, RPC209094H, RPC209769H, RPC209798H, RPC210170H, RPC205826H, RPC207390H, RPC207142H, RPC207478H, RPC208311H, RPC203647H, RPC206359H, RPC207078H, RPC207396H, RPC208381H, RPC208947H, RPC209378H, RPC202428H, RPC202683H, RPC202726H, RPC203027H, RPC203220H, RPC203867H, RPC204096H, RPC204178H, RPC204208H, RPC204396H, RPC204397H, RPC205261H, RPC205262H, RPC205270H, RPC205509H, RPC205814H, RPC207024H, RPC207456H, RPC207616H, RPC207863H, RPC207884H, RPC208170H, RPC208662H, RPC208862H, RPC209755H, RPC210022H, RPC210237H, RPC202891H, RPC203576H, RPC204120H, RPC205635H, RPC202828H, RPC203564H, RPC205507H, RPC208333H, RPC209121H, RPC209435H, RPC208305H, RPC203404H, RPC203453H, RPC203856H, RPC203902H, RPC204525H, RPC205127H, RPC205154H, RPC205369H, RPC205897H, RPC205980H, RPC206408H, RPC210137H, RPC203017H, RPC203018H, RPC203019H, RPC203020H, RPC203021H, RPC203022H, RPC205488H, RPC205835H, RPC206960H, RPC206961H, RPC206968H, RPC206971H, RPC206972H, RPC206977H, RPC209834H, RPC210125H, RPC210127H, RPC210135H, RPC203858H, RPC203991H, RPC204893H, RPC208422H, RPC207517H, RPC209504H, RPC210265H, RPC202497H, RPC203352H, RPC203385H, RPC204392H, RPC209059H, RPC202370H, RPC202390H, RPC204475H, RPC204480H, RPC204631H, RPC205912H, RPC207783H, RPC207790H, RPC207853H, RPC203671H, RPC204240H, RPC204414H, RPC206474H, RPC209270H, RPC202619H, RPC203225H, RPC204443H, RPC204688H, RPC208571H, RPC204310H, RPC204351H, RPC205048H, RPC206938H, RPC202912H, RPC203339H, RPC203359H, RPC203582H, RPC206617H, RPC204190H, RPC204437H, RPC209381H, RPC206926H, RPC204828H, RPC204835H, RPC205976H, RPC207597H, RPC208504H, RPC202674H, RPC203070H, RPC203331H, RPC203742H, RPC205091H, RPC205162H, RPC205290H, RPC205444H, RPC205589H, RPC206450H, RPC206601H, RPC206824H, RPC207052H, RPC207100H, RPC207428H, RPC207662H, RPC208860H, RPC209178H, RPC209384H, RPC209897H, RPC203868H, RPC204106H, RPC205404H, RPC205842H, RPC207180H, RPC207558H, RPC208453H, RPC208489H, RPC203289H, RPC204502H, RPC204969H, RPC205572H, RPC209078H, RPC209573H, RPC203571H, RPC208946H, RPC206151H, RPC202408H, RPC203703H, RPC204220H, RPC206301H, RPC207465H, RPC205289H, RPC207176H, RPC207391H, RPC203760H, RPC207892H, RPC203664H, RPC204100H, RPC204119H, RPC204255H, RPC204565H, RPC206026H, RPC206899H, RPC207220H, RPC207645H, RPC203585H, RPC204590H, RPC204641H, RPC209470H, RPC210106H, RPC204224H, RPC204662H, RPC205081H, RPC205662H, RPC206527H, RPC207173H, RPC209415H, RPC209937H, RPC205943H, RPC209416H, RPC209967H, RPC208126H, RPC208271H, RPC203187H, RPC204030H, RPC205642H, RPC205795H, RPC206116H, RPC206595H, RPC207138H, RPC207582H, RPC207989H, RPC208936H, RPC209326H, RPC209407H, RPC209426H, RPC207379H, RPC207521H, RPC207830H, RPC208452H, RPC209526H, RPC209671H, RPC209960H, RPC210088H, RPC208443H, RPC209286H, RPC204508H, RPC205372H, RPC206975H, RPC208222H, RPC209095H, RPC210017H, RPC202689H, RPC206858H, RPC204424H, RPC202488H, RPC204207H, RPC205294H, RPC205380H, RPC206878H, RPC207098H, RPC207254H, RPC208585H, RPC209681H, RPC210183H, RPC204273H, RPC205248H, RPC207074H, RPC203817H, RPC204285H, RPC204967H, RPC206149H, RPC2... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide - Worldwide Distribution
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 28, 2023
- Recall initiation date
- May 10, 2023
- Center classification date
- Jun 16, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.